地洛他定治疗慢性特发性荨麻疹多中心双盲对照临床试验

Efficacy and safety of desloratadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, comparative multicenter trial

目的:评价地洛他定治疗慢性特发性荨麻疹的有效性及安全性。方法:采用多中心、双盲、双模拟阳性对照研究,随机分为试验组和对照组。试验组口服地洛他定,对照组口服氯雷他定,均为1片/次,1次/d,连续服用14d。分别于用药后第1、2周随访,2周末评价疗效与不良反应。结果:入组患者116例,可评价疗效与安全性例数分别为111例和116例。试验组与对照组的总有效率分别为91.23%和90.74%(P>0.05)。两组的不良反应发生率分别为20.69%和16.36%(P>0.05)。结论:地洛他定治疗慢性特发性荨麻疹安全、有效,与氯雷他定相当。

Objective： To study the efficacy and safety of desloratadine in chronic idiopathic urticaria （CIU）. Methods： This study was a randomized, double-blind, double-analog comparative muhicenter trial of 2 weeks＇duration. Patients were randomly allocated to receive either desloratadine （n =58） or loratadine one tablet （n=58） once-daily for 14 days, and followed up at 7th day and 14th day after treatment. Results： Of the 116 patients who enrolled the study, 111 cases and 116 cases could be evaluated the efficacy and safety respectively. The total response rates of desloratadine and loratadine were 91.23% and 90.74% , respectively （P〉0.05）. The adverse reactions rates were 20.69% and 16.36% （P〉0.05）. Conclusion： Both desloratadine and loratadine are well tolerated and effective in the treatment of CIU.